510(k) Report

FDA applicant

Kuo Tai Hospital Managements & Consultant Co., Ltd.

Taipei, TW1 decision2010–20100 recalls

FDA records 1 decision for Kuo Tai Hospital Managements & Consultant Co., Ltd. (Taipei, TW) in 2010: 1 510(k) clearance. All are in product code FMI (Needle, Hypodermic, Single Lumen). No recall is linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, general hospital panel, where it files most

How often FDA has decided Kuo Tai Hospital Managements & Consultant Co., Ltd.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2010

2010: 1
2010high 1 (2010) · low 0 (2011)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2010.

FIG. 1 — Kuo Tai Hospital Managements & Consultant Co., Ltd. by year, 2010–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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